Light and mild redux: heated tobacco products' reduced exposure claims are likely to be misunderstood as reduced risk claims

Abstract

Introduction: Heated tobacco products (HTPs) are being marketed in several countries around the world with claims that they are less harmful than combusted cigarettes, based on assertions that they expose users to lower levels of toxicants. In the USA, Philip Morris International (PMI) has submitted an application to the Food and Drug Administration (FDA) in 2016 seeking authorisation to market its HTPs, IQOS, with reduced risk and reduced exposure claims.

Methods: We examined the PMI's Perception and Behavior Assessment Studies evaluating perceptions of reduced risk claims that were submitted to the FDA and made publicly available.

Results: Qualitative and quantitative studies conducted by PMI demonstrate that adult consumers in the USA perceive reduced exposure claims as reduced risk claims.

Conclusion: The data in the PMI modified risk tobacco product IQOS application do not support reduced risk claims and the reduced exposure claims are perceived as reduced risk claims, which is explicitly prohibited by the FDA. Allowing PMI to promote IQOS as reduced exposure would amount to a legally sanctioned repeat of the 'light' and 'mild' fraud which, for conventional cigarettes, is prohibited by the US law and the WHO Framework Convention on Tobacco Control.

Keywords: advertising and promotion; non-cigarette tobacco poroducts; packaging and labelling; tobacco industry.

Figure 1

Reduced exposure and reduced risk messages used in study THS-PBA-03-US. Note: same messages are indicated by the same colour. PBA, Perception and Behavior Assessment.

Figure 2

Reduced exposure message and an example of marketing materials from study THS-PBA-05-REC-US. In study THS-PBA-05-REC-US, all marketing materials carried a reduced exposure claim. PBA, Perception and Behavior Assessment; PMI, Philip Morris International.

Figure 3

Participants in a quantitative study (THS-PBA-03-US, top panel) perceived health risk of IQOS to be significantly lower than health risks of combusted cigarettes, regardless of whether they saw a reduced exposure claim (Messages 1–4) or a reduced risk claim (Message 5) (p. 68). Similarly, participants in THS-PBA-05-REC-US (bottom panel) rated perceived health risks of IQOS lower than combusted cigarettes for all marketing materials with reduced exposure claim (pp. 56, 72, 86). Note: answers were no risk, low risk, moderate risk, high risk, very high risk and don’t know and were later converted into a 0–100 scale (0=no risk and 100=very high risk). Error bars represent 95% CIs from the mean. Connecting lines are only to highlight clustering of outcomes for each comparator along the y-axis across IQOS messages. Abbreviations for Smoking Status Group: FS, adult former smokers; LA-25 NS, adult never smokers aged between their state legal smoking age (18 or 21) to 25 years; NS, adult never smokers; PBA, Perception and Behavior Assessment; PMI, Philip Morris International; SG, Surgeon General; S-ITQ, adult smokers with the intention to quit combusted cigarettes; S-NITQ, adult smokers with no intention to quit combusted cigarettes.